Newborn hearing screening probes recalled over the potential for false passes
PATH is recalling MADSEN AccuScreen probes because distortions after a speaker replacement can mimic true DPOAE responses and may result in a false PASS outcome.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the distortions may produce a false PASS on a hearing screen, and no injuries are reported.
Plain-English summary
The MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe, part number 8-69-41100, is being recalled by PATH.
Following a component change in the DPOAE probe, a speaker replacement, technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. The firm states these distortions can mimic true DPOAE responses and may result in a false PASS outcome.
The record does not state a quantity. Affected units carry UDI-DI 04260223141355 with serial numbers listed in the enforcement record, including 1008852, 1008888, 1008916, 1008925 and 1008935. Distribution was to Wisconsin domestically and to Ireland internationally. The FDA has classified the action as Class II.
A false PASS on a hearing screen can leave a hearing problem undetected. The enforcement record reports no injuries. Facilities should follow the firm's instructions.
The recalled product
- Product
- MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
- Manufacturer
- PATH
- Hazard
- false-pass
- screening-test
- probe-distortion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part Number: 8-69-41100
- UDI-DI: 04260223141355
- Serial Numbers: 1008852
- 1008888
- 1008916
- 1008925
- 1008935
- 1008945
- 1008951
- 1008957
- 1008960
- 1008962
- 1008966
- 1008967
- 1008987
- 1008990
- 1009054
- 1009065
- 1009066
- 1009131
Distribution
Distributed in 1 state:
- WI
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